Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT07294768
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the VentCoach protocol', 'timeFrame': '1 year', 'description': 'Total number of patients to achieve adherence will be defined as documented reduction in mechanical power (MP) or MP less than 12 J/min, in the 16 patients assigned to the VentCoach group'}], 'secondaryOutcomes': [{'measure': 'Time to removal from ventilator', 'timeFrame': '1 year', 'description': 'Time to successful extubation, allocation to ECMO, or death reported in number of days'}, {'measure': 'Incidence of patient-ventilator dyssynchrony', 'timeFrame': '1 year', 'description': 'Number of patients to experience patient-ventilator dyssynchrony, defined as double triggering and flow starvation'}, {'measure': 'Overall use of sedation', 'timeFrame': '1 year', 'description': 'Total use of analgesia, converted to morphine equivalent'}, {'measure': 'Overall use of paralytics', 'timeFrame': '1 year', 'description': 'Total number of patients to require paralytics: bolus and infusion of neuromuscular blockade outside intubation procedure'}, {'measure': 'Oxygenation index', 'timeFrame': 'Baseline, end of treatment (up to 14 days)', 'description': 'Oxygenation index is calculated by the following equation: mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 and is reported as a single number.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials/cls-20555865', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with acute hypoxemic and/or hypercapnic respiratory failure.\n* Patients requiring intubation and mechanical ventilation for more than 24 hours.\n* VentCoach protocol is specific to volume controlled continuous mandatory ventilation (S-CMV).\n* Patient who are admitted to RMH 10-3/10-4 and MB 6BGF ICUs.\n* Age greater than or equal to 18 years.\n* Patient's legal representative should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.\n\nExclusion Criteria:\n\n* Intubation and mechanical ventilation for airway protection in the setting of procedures/surgeries, e.g. interventional radiology, surgery, or endoscopy.\n* Intubation and mechanical ventilation due to drug overdose with expected extubation of less than 24 hours.\n* Intubation and mechanical ventilation in the setting of cardiac arrest.\n* Intubation and mechanical ventilation for a primary neurological etiology, e.g. increased intracranial pressure, tumor mass effect, ischemic/hemorrhagic stroke, status epilepticus, etc.\n* Mechanical ventilation to be guided by esophageal balloon.\n* Subject deprived of freedom, minor, subject under a legal protective measure.\n* Change in end-of-life decision anticipated after enrollment (or estimated 6-month mortality rate of greater than 50%).\n\nNote: prone positioning is not a contraindication for participation."}, 'identificationModule': {'nctId': 'NCT07294768', 'briefTitle': 'Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure: A Feasibility, Double Arm, Single-blinded Study', 'orgStudyIdInfo': {'id': '23-004855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Patients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'VentCoach', 'description': 'Patients randomized to the VentCoach group, in addition to the standard of care, will also receive intermittent ventilator setting adjustments per the VentCoach protocol', 'interventionNames': ['Other: VentCoach', 'Other: Standard of Care']}], 'interventions': [{'name': 'VentCoach', 'type': 'OTHER', 'description': 'VentCoach, a mechanical power-guided lung protective ventilation protocol, will be used to set ventilator adjustments.\n\nVentCoach ventilator assessments and adjustments will be performed within one hour after enrollment, and then every 4 hours thereafter', 'armGroupLabels': ['VentCoach']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Intubated patients will be managed per the standard of care ARDSnet-based mechanical ventilation management at Mayo Clinic, with routine RT/MD assessments, and ventilator setting changes as necessary for the treatment of the patient.', 'armGroupLabels': ['Standard of Care', 'VentCoach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Gustavo A. Cortes Puentes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gustavo A. Cortes Puentes', 'investigatorAffiliation': 'Mayo Clinic'}}}}